Kornimate/medical-research-clean huggingface dataset:
evaluate the clinical effectiveness, safety and tolerability of sildenafil used in doses ≥20mg tid for the treatment of pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (revatio™) for the treatment of pulmonary arterial hypertension (pah). the primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of pah.

the study design proposed is a retrospective chart review going back five years (01 april 2006 estimate) from the time of study initiation (31 march 2011 estimate). within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of pah for a period of at least three months. the patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of pah.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age at study index; * patients must have a diagnosis of pah. pah is conventionally defined as a mean pulmonary arterial pressure (pap) of \> 25 mmhg and a pulmonary capillary wedge pressure (pcwp) ≤ 15 mmhg and a pulmonary vascular resistance (pvr) ≥ 240 dynes/s/cm-5 at right heart catheterization; * patients must have initiated sildenafil for the treatment of their pah; at dose ≥ 20 mg tid within 5 years prior to study initiation exclusion criteria: * patient has known contraindications to sildenafil at study index; * patient participated in an investigational study of sildenafil treatment for pah during the period beginning 6 months prior to study index

Keywords: pulmonary arterial hypertension sildenafil citrate revatio
hemitox : effect of botulinum toxin injections on motor and functional ability of upper limb in adults at earlier phases of spastic hemiplegia after stroke

Conditions: Hemiplegia

Summary: botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. this study will test if botulinum toxin injections at earlier phases (\ or = 6 months).


Eligibility criteria:
inclusion criteria: * minimum age 18 * spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months. * antispasticity medication stabilized for the last 30 days * severe cognitive impairment such that patient is unable to provide scale assessment. * significant spasticity impeding improvement by re-education for 2 months or less * lack of muscular retraction defined by a minimal range of articular motion as : * finger : complete extension and rolling up * wrist : extension 40°/flexion : 45° * elbow : extension - 10°/flexion : 120° * shoulder : enjalbert score 2 or more * antagonist muscles (to spasticity) activity score 1 or more * social security benefits exclusion criteria: * ischemic stroke thought to be due to basilar or vertebral vessel occlusion * known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy) * absence of mobility in proximal part of upper limb that does not predict a functional gain * minor stroke with non-disabling deficit or rapidly improving motor symptoms * other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment * treatment of spasticity by previous administration of botulinum toxin, if known * known allergy to botulinum toxin * currently participating in other research studies

Keywords: spasticity ; botulinum toxin ; upper limb ; motor function. spastic hemiplegia after stoke
croatian version of the ocular surface disease index questionnaire (osdi)

Conditions: Dry Eye; Ocular Surface Disease

Summary: ocular surface disease index (osdi) questionnaire is an important tool for the diagnosis of dry eye disease. croatian version is yet not available. with a permission of abbvie company investigators want to make a croatian version of the ocular surface disease index questionnaire (cro-osdi).

aim is to translate, adapt and validate the croatian version of the ocular surface disease index (osdi) questionnaire. validation process of the croatian version of the osdi questionnaire will be accomplished in two phases: the translation and assessment of psychometric properties. the translation process will involve the following steps based on the previously established guidelines. first is forward translation, the second is backward translation and the third is pilot study. the final version (the cro-osdi) will be used to test psychometric properties of the croatian version of the questionnaire. eligible participants will complete the cro-osdi and and the previously validated croatian version of the national eye institute visual functioning questionnaire (nei vfq-25). after completing the respective questionnaires, the participants will undergo a complete ophthalmic examination for both eyes and dry eye tests (corneal fluorescein staining, lissamine green staining, schirmer test type i and ii, tear break-up time (tbut), noninvasive tear breakup time (nibut)).

Eligibility criteria:
inclusion criteria: * native croatian-speaking participants with normal cognitive ability * ded diagnosis complied with those defined by the dews ii * ded for at least 3 months * bcva logmar\< 0.6 or better exclusion criteria: * symptoms of conjunctivitis * a history of contact lens use * previous intraocular or ocular surface surgeries within the previous 6 months * allergies * eyelid malpositions * ptosis * parkinson disease * hereditary corneal disease * any other disease that could affect blinking
mri-guided radiation therapy in treating patients who have undergone surgery to remove the prostate

Conditions: Prostate Cancer; Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Summary: this is a prospective clinical trial examining the use of mri to measure internal organ motion and any resulting changes in the target volume (shape and location) during a course of post-operative radiation therapy for prostate cancer. the goal is to better understand and characterize these physiologic variations so that they can be accounted for during the treatment planning process. the ultimate longer-term clinical goal here is to provide a form of adaptive radiation therapy in the future, such that if major changes are seen over an 8-week course of radiation therapy in our study. this may argue for hypofractionating those patients who are most likely to have major shifts over time.

primary objectives: i. to evaluate the use of mri in delineating clinical target volumes, as well as endorectal balloon target immobilization in patients treated with radiation following radical prostatectomy. secondary objectives: ii. trends over time in ctv, bladder and rectum volumes and percent change from baseline at each time point. iii. frequency of events in which the ctv falls outside the ptv. iv. proportion of the total ctv which falls outside the ptv at each event. v. trends over time in dose-volume exposures for bladder and rectum. outline: patients undergo mri and ct scan-based simulation for treatment planning with endorectal balloon target immobilization. the treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved. patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. patients also undergo weekly mri scans of the pelvis (in the planned treatment position) during radiotherapy.

Eligibility criteria:
inclusion * completion of a radical prostatectomy for adenocarcinoma of the prostate * scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer * subjects are capable of giving informed consent exclusion * the presence of grossly visualized or palpable disease recurrence * patients who are unable to undergo an mri scan such as those with an implanted permanent pacemaker or icd * patients with metastatic disease or an increasing psa
a phase i clinical trial of bat4406f injection in patients with neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica Spectrum Disorders

Summary: this study is a phase i clinical study of the safety, tolerability, and pharmacokinetics of bat4406f injection in patients with neuromyelitis optica spectrum disorders.

this is a phase 1, open-label, dose-escalation study in nmosd patients in which subjects will receive bat4406f injection via intravenous infusion. a 3 + 3 design will be utilized to define a maximum tolerated dose (mtd). the overall objective is to assess the safety, tolerability, and pharmacokinetics of bat4406f injection in nmosd patients.

Eligibility criteria:
inclusion criteria: * compliance with the nmosd diagnostic criteria developed by the 2015 international nmo diagnostic team (ipnd); * 18-65 years old , male or female; * at least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening; * discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline; * edss score ≤ 6; * men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion; * agree to participate in the trial and sign the informed consent in writing. exclusion criteria: * any monoclonal antibody treatment was used within 6 months prior to dosing; * having been treated with anti-cd20 monoclonal antibody; * live vaccine received within 4 weeks before screening; * having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer); * a history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs; * abnormal liver function, kidney function and bone marrow reserve; * hiv-positive history or hiv-positive at screening; hepatitis b and/or hepatitis c history or hepatitis b surface antigen-positive at screening; or hepatitis c virus (hcv) antibody positive; treponema pallidum antibody positive when enrolled; * history of infections that investigators have identified as unsuitable for testing; * patients with a clear history of heart disease ; * have a history of mental disorders; * pregnant or lactating women, and female subjects who have a positive pregnancy test at screening; * none of the investigators or their relatives participating in the study could be enrolled.
the efficacy and safety of pyrotinib, trastuzumab combined with taxanes in the treatment of trastuzumab-treated her2+ advanced breast cancer (abc).

Conditions: HER2-positive Breast Cancer; Advanced Breast Cancer

Summary: this is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with pyrotinib + trastuzumab + taxanes. taxanes will be used for 6-8 cycles or discontinued due to intolerable adverse events (aes), after which capecitabine will be used for rhythmic chemotherapy combined with pyrotinib + trastuzumab. the aim is to explore the efficacy and safety of pyrotinib, trastuzumab, and taxanes in treating trastuzumab-treated her2+ advanced breast cancer (abc).


Eligibility criteria:
inclusion criteria: 1. age: 18-70 years old, female; 2. pathological examination confirmed her-2 positive invasive breast cancer; (her2 positivity is defined as an immunohistochemical (ihc) score of 3+ or in-situ hybridization (ish) result for her2 gene amplification in \>10% of immunoreactive cells. her2 positivity needs to be verified by the pathology department of the research center involved in this study) 3. imaging confirmed recurrent/metastatic breast cancer; 4. patients who relapsed and metastasized three months after discontinuation of trastuzumab treatment; 5. have at least one measurable lesion (according to recist 1.1 criteria); 6. ecog score of 0-2; 7. expected life span ≥3 months; 8. normal major organ function; 9. the researcher believes that the participant may benefit; 10. volunteer to participate in this study, sign informed consent. exclusion criteria: patients who meet any of the following criteria are not eligible for participation: 1. have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (nci-ctcae 5.0 grade \> 3); 2. patients in advanced stages who have undergone systemic treatment; 3. a history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction; 4. suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.; 5. currently suffering from severe liver-related diseases, such as acute hepatitis, explosive hepatitis, coagulation factor synthesis disorder, etc.; those who are positive for hbv surface antigen or hbv core antibody must have a peripheral blood hepatitis b virus dna titer test \< 1×10 \^3 iu/ml in order to participate; 6. comorbidity or condition that may interfere with their participation in the study, or any serious medical impediment that might affect participant's safety (such as, active or uncontrolled infection, active liver/gallbladder disease requiring antiviral treatment); 7. other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol; 8. having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study; 9. any circumstance that the researcher considers the participant unfit to participate in the study.
racial differences in vagal control of glucose homeostasis

Conditions: Obesity

Summary: the investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore pns activity and reduce oxidation in aaw compared to whites.

obesity has a greater detrimental impact on the health of african american women (aaw) than on any other racial or gender group. nearly 80% of aaw are overweight or obese. reduced insulin sensitivity is more prevalent among aaw as compared to white women and men of both races. this condition puts aaw at increased risk for the development of type 2 diabetes mellitus. the exact mechanism underlying these pathophysiological differences remains unknown. the investigators have found that obese aaw have decreased parasympathetic nerve (pns) activity compared to whites and recent studies in animal models showed that the pns confers protection against oxidative stress. in our aa cohort, pns activity was directly correlated with insulin sensitivity in obese aaw even after controlling for differences in age, blood pressure and visceral adiposity. equally important, the investigators also showed that the decrease in insulin sensitivity was associated with increased oxidative stress as measured by plasma levels of f2-isoprostanes. taken together these findings lead us to hypothesize that the decreased pns activity in obese aaw compared to white women has deleterious effects on oxidative stress and insulin sensitivity.the investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore pns activity and reduce oxidation in aaw compared to whites.

Eligibility criteria:
inclusion criteria: * female * african american or white (race will be self-defined, but only subjects who report both parents of the same race will be included) * 18-60 years old * bmi 30-45 kg/m2 * not pregnant or breastfeeding exclusion criteria: * pregnant or breastfeeding * diabetes diagnosis (defined by the american diabetes association (ada) criteria)38 * cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (lv hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy. * arrhythmia (first-, second-, and third-degree atrioventricular (av) block) * significant weight change \>5% in the past 3 months * impaired hepatic function (ast and/or alanine transaminase (alt) \> one and one half times (1.5x) upper limit of normal range) * impaired renal function (egfr \<60ml/min) * users of strong inhibitors of cytochrome p450 3a4 (cyp3a4) or cytochrome p450, family 2, subfamily d, polypeptide 6 (cyp2d6) * users of other acetylcholinesterase inhibitors such as pyridostigmine or bethanechol * history of alcohol or drug abuse * mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study * inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
living alone is predictive of non-home discharge following elective total hip arthroplasty: a matched-pairs cohort analysis

Conditions: Arthropathy of Hip; Perioperative/Postoperative Complications

Summary: the goal of this observational study is to assess the effect of living alone on total hip arthroplasty thirty-day outcomes. the main questions it aims to answer are: is living alone associated with discharge disposition (home versus non-home)? is living alone associated with greater incidences of secondary adverse events? participants will be sampled from the 2021 american college of surgeons national surgical quality improvement program


Eligibility criteria:
inclusion criteria: * elective, non-emergent cases * living alone * living with others exclusion criteria: * fracture in surgical diagnosis * hospital admission \>1 day preoperatively * end-stage renal disease (preoperative) * metastatic disease (preoperative) * sepsis (preoperative) * bleeding diathesis (preoperative) * american society of anesthesiologists physical status classification 5
effects of exercise on physical fitness among hemodialysis patients with chronic kidney disease

Conditions: Hemolysis

Summary: regular physical exercise was adapted to the situation of the patient with hemodialysis to help improve the quality of life of the patient

it has been observed that programs that combine aerobic and resistance exercise can increase muscular strength and endurance, functional capacity and quality of life of patients in hemodialysis. aerobic exercise and muscular endurance during dialysis increase blood flow at the muscular level with an increase in capillary surface area, which dynamizes the flow of urea and toxins from the tissues to the vascular compartment, which could improve the effectiveness of dialysis in addition, moderate regular exercise can modulate the inflammatory response, which would be beneficial in patients with chronic kidney disease

Eligibility criteria:
inclusion criteria: * famel and male between 55 - 85 year old. in hemodyalisis treatment exclusion criteria: * younger than 55 years and older than 85 years. * presenting myocardial infarction in the previous 6 weeks. * unstable angina to exercise or at rest. * recent cerebral vascular disease or with risk of recurrence. * musculoskeletal, respiratory (copd with frequent decompensation). * hypertensive disorders, patients with peripheral vascular disease, * active liver disease. * osteoporosis diagnosed, in which the medical criterion is contraindicated physical exercise. * solution of problems of the following circumstances: * fraction of cardiac ejection \<of 45%, hb \<of 10gr / dl. * problematic vascular access, both immature fistulas or with risk of extravasation and catheter dysfunctions of postural characteristics.

Keywords: hemodialysis klotho protein excercise lifestyle condition
the impact of phone use on everyday outcomes

Conditions: Obesity; Sleep; Depression; Anxiety

Summary: participants will download a phone-tracking app for a week to track phone usage, providing objective data on usage patterns. quantitative tasks and questionnaires will also be carried out before and after the tracking period.

a notable shortcoming of existing mobile phone research is that 'phone use' has almost exclusively been measured through subjective reports - by simply asking respondents how much time they spend on their mobile phones each day. this operational definition, however, is a major shortcoming as phone use is difficult to track - and is thus likely to be highly inaccurate. to address this gap, the investigators describe in this proposal a first step to characterize phone usage in an objective manner - by asking adolescents to download a phone-tracking app for a week. this circumvents measurement errors inherent to self-reports, and allows us to probe: (1) how accurate adolescents' estimates are of their own phone usage, and (2) whether objective phone usage predicts any cognitive, socio-emotional, or physical outcomes. the completion of this study will represent an important step forward in the development of empirically-driven guidelines on phone use amongst adolescents.

Eligibility criteria:
inclusion criteria: * owns a smartphone exclusion criteria: * parents not willing to give consent * history of medical or psychiatric disorder * history of motion sickness, dizziness or epilepsy

Keywords: smartphone screen time
removal of endotracheal tube secretions comprehensively until extubation

Conditions: Mechanical Ventilation; Pneumonia

Summary: the purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (complete airway management catheters: cam rescue cath and cam endotrach cath).

thirty mechanically ventilated adult patients will be managed with standard suction catheters. just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. the endotracheal tubes will then be cleaned using the cam catheters (rescue cath followed by endotrach cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.

Eligibility criteria:
inclusion criteria: * patients receiving medical care in adult intensive care unit setting * patients who have been intubated and mechanically ventilated for at least 12 hours * patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater exclusion criteria: * patients receiving medical care in a setting not compatible with an adult intensive care unit * patients who have been intubated and mechanically ventilated for less than 12 hours * patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less * patients intubated with dual lumen or steel-reinforced endotracheal tubes

Keywords: endotracheal tube obstruction, occlusion mechanical ventilation, complication work of breathing airway resistance secretions pneumonia, ventilator associated biofilms endotracheal tube